U.S. patent application number 14/285526 was filed with the patent office on 2014-09-18 for female luer connector disinfecting cap.
The applicant listed for this patent is IVERA MEDICAL CORPORATION. Invention is credited to Gino Kang, Bobby E. Rogers.
Application Number | 20140261558 14/285526 |
Document ID | / |
Family ID | 44857293 |
Filed Date | 2014-09-18 |
United States Patent
Application |
20140261558 |
Kind Code |
A1 |
Rogers; Bobby E. ; et
al. |
September 18, 2014 |
FEMALE LUER CONNECTOR DISINFECTING CAP
Abstract
A cleaning device for a site of a medical implement is
disclosed, as are methods for using such devices. The cleaning
device can include a cap having an opening to an inner cavity, and
the opening can be adapted to receive a site of the medical
implement. The inner cavity can include a male luer protrusion that
extends up from an inner wall toward the opening, and can be sized
and adapted for insertion into a female luer when the cap is
provided on the medical implement. The cleaning device can further
include a cleaning material that contains a cleaning agent prior to
receipt of the site of the medical implement, i.e. the cleaning
material is pre-loaded with the cleaning agent. The cleaning
material can be at least partially secured in the inner cavity and
adapted to swab and clean the site with the cleaning agent. The cap
can further include a friction-forming member for creating a
friction-based fitting of the cap onto the site of the medical
implement.
Inventors: |
Rogers; Bobby E.; (San
Diego, CA) ; Kang; Gino; (Irvine, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
IVERA MEDICAL CORPORATION |
SAN DIEGO |
CA |
US |
|
|
Family ID: |
44857293 |
Appl. No.: |
14/285526 |
Filed: |
May 22, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13099324 |
May 2, 2011 |
|
|
|
14285526 |
|
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|
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61330243 |
Apr 30, 2010 |
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Current U.S.
Class: |
134/22.1 |
Current CPC
Class: |
A61B 90/70 20160201;
A61M 39/162 20130101; B08B 1/003 20130101; A61M 39/16 20130101;
B08B 3/08 20130101; A61M 39/20 20130101 |
Class at
Publication: |
134/22.1 |
International
Class: |
A61B 19/00 20060101
A61B019/00 |
Claims
1. A method of cleaning a female port having a lumen, the method
comprising: receiving, in an opening of a cap, a portion of the
female port, the opening providing access to a single inner cavity,
the single inner cavity including an upwardly directed protrusion
extending up from an inner wall of the inner cavity toward the
opening; inserting the upwardly directed protrusion into the lumen
of the female port; securing the cap onto the female port; and
cleaning, with a cleaning material provided in the single inner
cavity encircling at least a base of the upwardly directed
protrusion and upon receipt of the female port into the single
inner cavity, at least one surface of the female port, the cleaning
material comprising a cleaning agent.
2. The method in accordance with claim 1, wherein the cleaning
material is a thixotropic fluid.
3. The method in accordance with claim 1, wherein the cap further
comprises a friction forming member extending out from an inside
surface periphery of the opening to the single inner cavity.
4. The method in accordance with claim 3, wherein the friction-
forming member includes a threading having a gauge that increases
inwardly from the opening toward the inner wall of the cap.
5. The method in accordance with claim 3, wherein the friction
forming member includes a threading that defines a decreasing
diameter of the single inner cavity from the opening toward the
inner wall of the cap.
6. The method in accordance with claim 1, wherein the opening of
the cap is oval-shaped.
7. The method in accordance with claim 1, wherein the cap further
comprises one or more energy directors extending up from the inner
wall toward the opening to the single inner cavity.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional under 35 U.S.C. .sctn.120
of co-pending U.S. patent application Ser. No. No. 13/099,324,
filed on May 2, 2011 and entitled "Female Luer Connector
Disinfecting Cap," which claims priority under 35 U.S.C.
.sctn.119(e) to U.S. provisional patent application Ser. No.
61/330,243, which was filed on Apr. 30, 2010. The current
application is also related to co-pending and co-owned U.S. patent
application Ser. No. 11/705,805, filed Feb. 12, 2007 and entitled
"Medical Implement Cleaning Device." The disclosures of each of the
applications cited in this paragraph are incorporated herein by
reference in their entireties.
BACKGROUND
[0002] The present invention relates to cleaning devices, and more
particularly to a universal connector cap capable of cleansing a
connector of pathogens or other harmful materials or contaminants,
for example by employing a friction-based fitting to a connector
site or other medical implement.
[0003] In the medical field, there is often a need to connect
tubing to a variety of devices to facilitate the administration of
fluids to a patient. To allow tubing and components from different
manufacturers of a variety of devices to connect with one another,
a standard connector type was developed. The connector type
generally consists of a male connector (or "port," which is used
interchangeably herein) being inserted into a female connector
whereby friction can keep them together. The taper of the male
connector can be adapted to closely match the taper of the female
connector to create a friction or compression type connection that
is fluid tight. For infusion or aspiration of fluids to or from an
intravenous or arterial access line or device, i.e. including,
without limitation, a catheter, IV set, extension set stopcock,
syringe, valve, etc., this type of connector is known as a Luer
fitting, a Luer connector, a Luer lock, or the like. The dimensions
of Luer connectors, which are referred to herein generically as a
"Luer" or "Luers," can be found in ISO Standards 594-1 and
594-2.
[0004] Luers were later improved with threading mechanisms to allow
and assist the two connectors to screw together, whereby friction
was again the holding force. This threading was merely an
enhancement to enable a user to more easily drive the male and
female connectors together. If a female port remains open when not
connected, there is an increased risk of infections, leakage of
fluid and other problems resulting from having open access to the
patient. To eliminate this "open" problem, a rubber port can be
used for the female connector that can keep the female port closed
until used for injections. The rubber port was typically pierced
with a needle, or can be removed to connect the female connector
with other tubing.
[0005] The female connector was further improved with one of
several other features, such as a split septum, biased septum,
displaceable piston etc. that can be displaced from a closed
position by the male connector when it needs to be out of the way,
but which can spring back to the closed position as required. This
device was highly desirable because it eliminated the dangerous
needle and its closure was automatic. This device is commonly
called a needleless adapter, or a Luer Activated Valve (LAV). For
instance, the Luer tapered male port on standard syringes can open
a fluid path without a needle, through or around the displaced
feature on the female side when the two were pressed or screwed
together. After the injection of fluids, the syringe was
unscrewed/removed. Upon removal, the needle-free feature (whether a
biased plug/piston, split septum or other displaceable construct)
is, without user interaction, automatically biased back into its
normally closed position.
[0006] This improvement simplified the administration of fluids by
removing needles and reducing open port risks but still
necessitated the use of a disinfecting wipe prior to insertion
since the outside features of the connection can still remain
exposed to touch and air contamination.
SUMMARY
[0007] This document describes features of cleaning devices for
medical implements as well as methods for using such devices. In
one aspect, a cleaning device includes a cap having an opening to
an inner cavity. The opening is adapted to receive a site of the
medical implement. The inner cavity includes a male Luer protrusion
that extends up from an inner wall toward the opening, and is sized
and adapted for insertion into a female Luer when the cap is
provided on the medical implement. The cleaning device further
includes a compressible cleaning material that surrounds the male
Luer protrusion and that contains a cleaning agent prior to receipt
of the site of the medical implement, i.e. the cleaning material is
pre-loaded with the cleaning agent. The compressible cleaning
material is at least partially secured in the inner cavity and
adapted to swab and clean the site with the cleaning agent,
including cleaning the female Luer and inner lumen therein.
[0008] The cap can further include a friction-forming member for
creating a friction-based fitting of the cap onto the site of the
medical implement. Alternatively, the cap further includes a
member, for example one protruding from threading at the opening of
the inner cavity, that, once the cap is fitted onto the site of the
medical implement, inhibits easy removal of the cap until a force
exerted on the cap exceeds a certain threshold of force. The cap
can further include one or more energy directors on which a
threaded ring is mated to a receptacle in the cap. The cap can be
filled with a cleaning material and cleaning solution, such as a
foam pad with an antibacterial or antimicrobial solution.
Alternatively, the cap can be filled with a gel, foam or wax that
includes an antibacterial or antimicrobial component.
[0009] The details of one or more embodiments are set forth in the
accompanying drawings and the description below. Other features and
advantages will be apparent from the description and drawings, and
from the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] These and other aspects will now be described in detail with
reference to the following drawings:
[0011] FIG. 1 shows a male cleaning device;
[0012] FIG. 2 shows a variation of a cleaning device;
[0013] FIG. 3 shows yet another variation of a cleaning device;
and
[0014] FIG. 4 shows a process flow chart showing at least one
feature consistent with an implementation of the current subject
matter.
[0015] When feasible, like reference symbols in the various
drawings indicate like elements.
DETAILED DESCRIPTION
[0016] An improved cleaning device has been created that acts as a
combination cap and disinfecting swab whereby it screws on or is
otherwise fitted onto the closed female side of a Luer activated
valves (i.e. LAV). The cleaning device contains features to
disinfect or sterilize the external surface of the closed female
port, and further protects the surface from further contamination
as long as it remains fitted on to the female port. The cleaning
device includes the male feature, i.e. the tapered cone or tapered
cylinder, to open the female Luer valve as well as clean the outer
and inner surfaces of the Luer valve around the septum. Luer
activated valves are typically made of very rigid plastics such as
polycarbonate or acrylic. The female connection of the Luer has
threads and a root diameter.
[0017] A cleaning device in the form of a cap to clean the female
connection can be provided as exemplified in U.S. patent
application Ser. No. 11/705,805, filed Feb. 12, 2007, the contents
of which are incorporated herein by reference for all purposes. The
cleaning device for a medical implement includes a cap having an
opening to an inner cavity. An inner surface of the opening
includes one or more threads adapted to receive a site of the
medical implement. The cleaning device further includes a cleaning
material formed of a compressible material that is at least
partially secured or supported in the inner cavity. The cleaning
material contains a cleaning agent that effectively eliminates
pathogens and other harmful materials from the site and that can be
activated from the cleaning material by twisting and fitting the
cap onto the site, particularly if the cap is fitted onto the site
for a period of time.
[0018] The one or more threads of the cleaning device can be
provided by a threaded ring adapted to be fixedly positioned at the
inner surface of the opening of the cap. Two threads encircle
approximately one-quarter to one-half of the inner surface of the
threaded ring. A tab extends from each thread, preferably at the
lower terminus of each thread. The tab can be made thinner than the
rest of the thread, to allow flexure or bending. The threaded ring
can be formed by plastic injection molding. The threads are formed
such that the threaded ring does not need to be unwound during
molding or fabrication. The tabs of each thread engage with the
outer threading of a valve or port, and any gap provided thereby
allows for compatibility with many sized valves or ports, as well
as allows limited evaporation of cleaning solution (such as
isopropyl alcohol) that might be inside the cap.
[0019] The tabs create friction on one or both outer sides of the
female connection of the Luer, thereby preventing the cap from
unscrewing from the female connection of the Luer. In some
implementations, the threads of the cap correspond to an ISO Luer
Standard thread. Each tab presses against the root diameter of the
female Luer and presses on the sides of the thread feature of the
female connection, thereby creating friction. The threading and one
or more protrusions cooperate to create a compression fit and to
prevent the cap from accidentally coming off the site onto which it
is fitted.
[0020] The threads of the cap, and/or the protrusions of added
material, can be made of a softer, more compressible material than
the cap or the female connector, such as another type of plastic or
a rubber, etc. The features pressing on the female side can work in
several ways. The added material can press against the more rigid
female LAV root or body or threads to create friction. The added
material can also displace plastic to create a single use scenario,
where the part pressing on the thread pushes against the outside of
the thread or on the sides of the thread. The material can further
deflect in a variety of ways to make putting on simple, and taking
off more difficult.
[0021] Additionally the cap can be configured for being pressed on
instead of, or in addition to, being screwed on, with material that
protrudes from the inner ring or threads of the cap to press
against the threads or roots of the female connection of the LAV,
similar in function to a star retaining washer. It can have simple
features on the press parts that create resistance when pulled off.
The protruding "flaps" can be bendable to allow the cap to be
forced over the female threads. Once past the threads or a section
of threads, the "flaps" can naturally return to their unbent state
to prevent the inadvertent removal of the cap. To remove, it may be
possible to unscrew the cap where the flaps find the thread track,
but the user can just pull off the cap upon exceeding a certain
threshold force to overcome the resistance by the added material
and/or the threads of the cap.
[0022] FIG. 1 shows a cleaning device 100, including a cap portion
102 that includes a cap 104 with an opening 106 to an interior
cavity 107. The cap 104 can be formed of rigid plastic, such as
high density polyethylene (HDPE) plastic. A removable foil lid 108
is adapted to close the opening 106, and can be sealed on the top
outer periphery of the opening 106 by a heat or thermal process.
The opening 106 is slightly wider in diameter than the rest of the
interior cavity 107 to form a ring receptacle 110 and to be able to
receive a threaded ring 112 as described above. The threaded ring
112 can be ultrasonically welded, glued, or otherwise attached into
the receptacle 110. The ring receptacle 110 includes a number of
energy directors in the form of bumps or protrusions that enable
welding or bonding of the threaded ring 112 into the ring
receptacle 110. The energy directors also stabilize the threaded
ring 112 for proper alignment and mounting, and can resist against
turning the threaded ring 112 relative to the cap 104 when the
cleaning device 100 is screwed on or otherwise applied to a port or
valve.
[0023] The top interior wall 114 of the cap 104 includes a male
luer protrusion 116 extending up toward the opening 106 of the cap
104, preferably formed as a portion of a tapered cone or cylinder.
The male Luer protrusion 116 is ringed by cleaning material 118
formed of a compressible material that is at least partially
secured in the inner cavity 107. The depth or height 120 of the
cleaning material can be varied, but in preferred implementations
the compressible cleaning material is at least the same or shorter
height than height 122 of the top of the male luer protrusion
116.
[0024] The top interior wall 114 of the cap 104 can have one or
more protrusions 116 extending up from the interior wall 114 toward
the opening 106 of the cap 104. The one or more protrusions 116 can
be used to support a cleaning material 118 such as foam, cotton, or
other porous material, or provide stability to a thixotropic
cleaning solution as an alternative. The cleaning material exists
in the form of a doughnut. In some implementations, the one or more
protrusions 116 can be formed of a flexible material to contact and
scrub the forward face of a valve or port, such as the septum of a
valve.
[0025] The cleaning device 100 provides many advantages. For
example, the cleaning device 100 can be easily manufactured. The
cleaning device 100 can be easily fit on appropriate devices, such
as machines. Further, the cleaning device 100 can be manufactured
such that the cleaning device 100 fits any Luer thread. The
cleaning device can use different tools for threading. When using a
dialysis tube, an inner lumen of the hub, outside threads, and the
face of hub can optionally also be disinfected. Cores can be
redesigned using a custom tool to obtain new design caps. Length
and wings can be added to obtain a new tool for the cap. The new
tool can be a further enhancement to an existing tool.
[0026] FIG. 2 shows an alternative implementation 200 of a cleaning
device, similar to the device 100 shown in FIG. 1, in which the
male Luer protrusion 202 is formed of a plug of a cleaning material
(e.g. foam, cotton, or other porous material) 204 that is preloaded
with a cleaning agent 206 such as isopropyl alcohol. The cleaning
device 200 has a high confidence level of reducing or eliminating
infection. The plug 204 can include the protrusion 202 ringed by a
channel 208, and can also include side walls 210 surrounding the
outside of the channel 208. The plug 204 can be secured into the
interior cavity 212 of the cap by posts 213, by adhesive, or by a
series of barbs that extend up from the top interior wall 214 of
the cap 216. The posts 213 can be molded by a heat-staking process.
Any damage by heat staking can be prevented or minimized by using
suitable techniques.
[0027] FIG. 3 shows another implementation 300 of a cleaning
device, combining certain features from the devices (100, 200)
shown in FIGS. 1 and 2. The cap 302 is similar to the caps 104,
216, but the male Luer protrusion 304 can be integral with the cap
material 305, i.e. formed of a single mold. A molded "skin" of foam
or some other cleaning material layer 308 is overlaid on some or
most of the surface of the interior cavity 310, including the male
luer protrusion 304. The skin 306 can be soaked with a cleaning
agent 308, of a calculated amount to clean the inside and outside
surfaces of the female port near the septum. The male luer
protrusion 304 provides a seal with the inner lumen of the female
luer port. The skin 306 can be thermally bonded, glued, riveted or
otherwise attached to the cap material 305.
[0028] The inner cavity of the cap (104, 216, or 302) can include a
cleaning material laden with a cleaning solution. In some
implementations, the cleaning material is a foam material, and the
cleaning solution is a liquid that saturates the foam material.
Suitable cleaning solutions include isopropyl alcohol, ethyl
alcohol, CHG, choloroxylenol (PCMX), providone iodine, etc. The
cleaning solution can also include emollients or other
components.
[0029] In other implementations, the cleaning material and cleaning
solution can be formed of a thixotropic substance such as a gel or
foam, or of a fluid with high viscosity. The thixotropic substance
can include a base viscous substance impregnated with a cleaning
solution in a manner to maintain at least a certain degree of
viscosity. The thixotropic substance can at least partially fill
the interior cavity of the cap (104, 216, or 302), and flow around
the valve or port to cover a desired surface area when the cap
(104, 216, or 302) is placed on the valve or port.
[0030] FIG. 4 shows a process flow chart 400 showing at least one
feature consistent with an implementation of the current subject
matter. At 402, an opening of a cap receives a site of a medical
implement having a female port. The cap has an outer surface
including a plurality of vertical ridges on the outer surface while
the opening provides access to a single inner cavity that includes
a male luer protrusion extending up from an inner wall of the inner
cavity toward the opening. The cap also includes, around a
periphery of the single inner cavity, threading including a
friction-forming member for creating a friction-based fitting of
the cap onto the site of the medical implement. At 404, a cleaning
material, which includes a cleaning agent and is provided in the
single inner cavity surrounding the male luer protrusion upon
receipt of the site of the female port into the single inner cavity
and the insertion of the male luer protrusion into the septum of
the female port, cleans at least one surface of the female port
near a septum of the female port.
[0031] The implementations set forth in the foregoing description
do not represent all implementations consistent with the subject
matter described herein. Instead, they are merely some examples
consistent with aspects related to the described subject matter.
Although a few variations have been described in detail herein,
other modifications or additions are possible. In particular,
further features and/or variations can be provided in addition to
those set forth herein. For example, the implementations described
above can be directed to various combinations and sub-combinations
of the disclosed features and/or combinations and sub-combinations
of one or more features further to those disclosed herein. In
addition, the logic flows depicted in the accompanying figures
and/or described herein do not necessarily require the particular
order shown, or sequential order, to achieve desirable results. The
scope of the following claims may include other implementations or
embodiments.
* * * * *